Category Archives: Fluid Management Systems

Nalini S. Mahadevan has been appointed as General Counsel for Fluid Management Systems, Inc. Ms. Mahadevan earned her JD from the St. Louis University School of Law and MBA from Washington University, St. Louis, MO. She was a partner at Lowenbaum Partnership and a founding partner at Mahadevan Law Office, LLC, both in St. Louis. She has over 10 years of experience in federal law. She is also an Adjunct Professor at St. Louis University School of Law.

Fluid Management Systems is a high tech entrepreneurial company based in Lexington, Kentucky, USA. FMS is marketing a trademarked and patented product, VETrakTM, a proprietary system for managing inventory through a non-invasive measurement process. The initial focus is on food-animal feeding operations (AFO), such as swine and bovine markets. The products are also being developed for human health, pharmaceutical manufacturing, and medical dispensing cabinet for hospitals, clinics and AFOs.

On June 18th, the US Patent and Trademark Office (USPTO) granted FMS a utility patent for a system that manages inventory through a non-invasive measurement process. USPTO also approved a trademark — VETrak — for commercial applications. FMS has several pending provisional and utility patents for human- and animal-health applications.

The measurement system developed by FMS is envisioned as a system to track injectable medications administered in hospitals, clinics and doctors’ offices. The technology resulting from this vision is highly adaptable; the first iteration of the technology will be implemented in the animal-health market.

FMS is currently employing commercial VETrack units at swine farms in Illinois and Iowa. FMS is also in discussions with Lexington-based equine and pharma-manufacturing companies to expand the technology’s applicability to additional animal farms, as well as the human-health field.

As we wrote in a previous post in November, “Farm Use of Antibiotics Defies Scrutiny“, responsibility for regulating antibiotic use is splintered among multiple agencies: the FDA, USDA and CDC. The FDA polices drugs, a role they carry out by overseeing the meat sold in our supermarkets, and by monitoring the existence of bacteria that are resistant to antibiotics. The FDA is trying to get a handle on the kinds of antibiotics that are being fed to livestock, but to no avail — livestock facilities are not legally required, and are vehemently opposed, to divulge details about what drugs are administered to which animals, and in what amounts.

It seems as this point that the situation could be a matter of life and death. In 2011, the agricultural industry bought almost 30 million pounds of antibiotics — 80% of the US’s 2011 antibiotic sales — for animal use, the biggest quantity ever purchased. The drugs are mostly given to animals at low dosages in order to encourage growth, and to contain any sicknesses they might contract by living in such close quarters of each other and their waste. However, feeding livestock low levels of antibiotics can actually breeds antibiotic-resistant diseases.

In 2008, Congress forced drug companies to report to the FDA the amount of antibiotics they sold to agricultural facilities. Again, no information was released on what drugs were given to which animals, in what amounts and why.

The Senate Committee on Health, Education. Labor and Pensions reauthorized the Animal Drug User Fee Act (ADUFA) for 2013, requiring veterinary-drug companies to pay fees to the FDA as a way to financially support the agency. Two Democrats from the House have introduced new legislation that would give FDA the authority to amass more data from drug companies, as well as make food producers reveal how frequently they give low doses of antibiotics to animals, so as to spur growth and offset poor conditions.

We believe that in order to lower societal costs, and protect animals and humans, open and objective debate needs to continue among all stakeholders.

Healthcare and drug companies are looking to join a market largely held by hospitals: injectable drugs, a $7 billion industry that often experiences shortages.

Drug mogul Becton Dickinson (BD), for example, plans on introducing 20-30 new injectable medicines to the US over the next few years, some of which have been in short supply. International drug companies are also seizing the market. Jordan-based Hikma Pharmaceuticals will launch 5-10 products in the next few years, also introducing a few of which have been scarce.

Companies like BD are attracted to this market because of the supply issue; and while sterilizing injectable drugs can prove difficult, the payoff is big: almost one billion vials are sold each year. However, companies might have to wait for the long-run, as producing sterile medicines can be expensive with low profits. Many companies left the market due to the cost, leaving some drugs to just one manufacturer. In addition, manufacturing problems, supply constraints and government investigation of manufacturing plants have pushed many drug firms to abandon facilities or slow down production.

What resulted was an even larger shortage in 2011: 183, as opposed to 23 five years earlier. According to the FDA, the shortages fell to 84 in 2012, partly because Pfizer began manufacturing limited cancer injectables and some plants, which were previously shut down, reopened.

Yet, in order to turn a profit, many companies are looking into raising prices by 10%. This would greatly affect hospitals and their drug buyers, who will most likely fight the increases. In order to cut costs and availability, drug companies should consider producing and selling drugs in multi-dose vials. Fluid Management Systems, Inc. has the technology to manage and monitor injectable drug inventories in multi-dose vials.